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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-003019-39 | EudraCT Number |
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| Name | Class |
|---|---|
| Public Health England | OTHER_GOV |
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The UK Departments of Health now recommend annual influenza vaccination for all children 2-7 years of age, with children over 7 years eligible for vaccination if in certain higher risk clinical categories. Though data are available documenting the safety and immunogenicity of LAIV in this age group, there are little data to assess efficacy and immune correlates in UK children, and in particular atopic children. This study will enrol 200 children (and at least 200 unvaccinated household sibling controls), many with a history of asthma or recurrent wheezing, and allow an assessment of efficacy, safety and immune correlates in these children, and how this varies with prior administration of pandemic influenza vaccine and/or LAIV.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Administration of Live attenuated influenza vaccine (LAIV) as per national guidance. Surveillance thereafter through nasal swabbing in the event of influenza-like illness. |
|
| Controls | Other | Surveillance in siblings of participants in the Intervention arm, through nasal swabbing in the event of influenza-like illness, irrespective of their vaccination status. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Live attenuated influenza vaccine | Drug | Administration of LAIV, with subsequent surveillance (nasal swabbing) during influenza season |
|
| Measure | Description | Time Frame |
|---|---|---|
| Vaccine Efficacy | Vaccine efficacy will be assessed through documentation of the incidence of laboratory confirmed influenza and other respiratory viruses in the children receiving LAIV compared to unvaccinated sibling controls | During 2015/2016 influenza season - precise dates to be set by Public Health England as this varies annually. Approximate duration of 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Immune Response to LAIV | To assess the immune response to vaccine and non-vaccine influenza strains before and after a single dose of LAIV administration, with respect to i. serological measures (haemagglutination inhibition titre to specific influenza strain) ii. change in specific nasal IgA responses | Up to 6 weeks following administration of a single dose of LAIV |
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Inclusion Criteria:
Exclusion Criteria:
Hypersensitivity to the active ingredients, gelatin or gentamicin (a possible trace residue) [notwithstanding allergy to egg protein]
Previous systemic allergic reaction to LAIV
Previous allergic reaction to an influenza vaccine (not LAIV) is a relative contra-indication, which must be discussed with the site PI to confirm patient suitability
Children/adolescents who are clinically immunodeficient due to conditions or immunosuppressive therapy such as: acute and chronic leukaemias; lymphoma; symptomatic HIV infection; cellular immune deficiencies; and high-dose corticosteroids**.
**High-dose steroids is defined as a treatment course for at least one month, equivalent to a dose of prednisolone at 20mg or more per day (any age); or for children under 20kg, a dose of 1mg/kg/day or more.
Children and adolescents younger than 18 years of age receiving salicylate therapy because of the association of Reye's syndrome with salicylates and wild-type influenza infection.
pregnancy
Febrile ≥ 38.0 'C in last 72 hours
Acute wheeze in last 72 hours requiring treatment beyond that normally prescribed for regular use by the child's treating healthcare professional
Recent admission to hospital in last 2 weeks for acute asthma
Current oral steroid for asthma exacerbation or course completed within last 2 weeks
Received any blood or blood products within the past 12 weeks
Any other significant condition or circumstance which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Paul J Turner | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperial College London / Imperial College Healthcare NHS Trust | London | W2 1NY | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Administration of Live attenuated influenza vaccine (LAIV) as per national guidance. Surveillance thereafter through nasal swabbing in the event of influenza-like illness. Live attenuated influenza vaccine: Administration of LAIV, with subsequent surveillance (nasal swabbing) during influenza season Surveillance (nasal swabbing) during influenza season |
| FG001 | Controls | Surveillance in siblings of participants in the Intervention arm, through nasal swabbing in the event of influenza-like illness, irrespective of their vaccination status. Surveillance (nasal swabbing) during influenza season |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Administration of Live attenuated influenza vaccine (LAIV) as per national guidance. Surveillance thereafter through nasal swabbing in the event of influenza-like illness. Live attenuated influenza vaccine: Administration of LAIV, with subsequent surveillance (nasal swabbing) during influenza season Surveillance (nasal swabbing) during influenza season |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Vaccine Efficacy | Vaccine efficacy will be assessed through documentation of the incidence of laboratory confirmed influenza and other respiratory viruses in the children receiving LAIV compared to unvaccinated sibling controls | Posted | Count of Participants | Participants | During 2015/2016 influenza season - precise dates to be set by Public Health England as this varies annually. Approximate duration of 3 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | Administration of Live attenuated influenza vaccine (LAIV) as per national guidance. Surveillance thereafter through nasal swabbing in the event of influenza-like illness. Live attenuated influenza vaccine: Administration of LAIV, with subsequent surveillance (nasal swabbing) during influenza season Surveillance (nasal swabbing) during influenza season NB: Adverse Events were not monitored/assessed for the Household "Controls" |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rhinitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Paul Turner | Imperial College London | +44 20 3312 7754 | p.turner@imperial.ac.uk |
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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| C000613429 | FluMist |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Surveillance (nasal swabbing) during influenza season | Procedure |
|
| Incidence of Adverse Events (AE) and Serious Adverse Events (SAEs) in Those Received LAIV | Incidence of adverse events (AE) and serious adverse events (SAEs) in children receiving LAIV, with the following sub-analyses:
NB: AE data was NOT collected in household controls, as per protocol NB: AE delay not collected in Controls (as per protocol) | Up to 1 month after LAIV administration |
| BG001 |
| Controls |
Surveillance in siblings of participants in the Intervention arm, through nasal swabbing in the event of influenza-like illness, irrespective of their vaccination status. Surveillance (nasal swabbing) during influenza season |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Controls |
Surveillance in siblings of participants in the Intervention arm, through nasal swabbing in the event of influenza-like illness, irrespective of their vaccination status. Surveillance (nasal swabbing) during influenza season |
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|
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| Secondary | Immune Response to LAIV | To assess the immune response to vaccine and non-vaccine influenza strains before and after a single dose of LAIV administration, with respect to i. serological measures (haemagglutination inhibition titre to specific influenza strain) ii. change in specific nasal IgA responses | 39 patients provided paired blood samples pre and post LAIV 89 patients provided paired oral fluid samples pre/post LAIV | Posted | Count of Participants | Participants | Up to 6 weeks following administration of a single dose of LAIV |
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| Secondary | Incidence of Adverse Events (AE) and Serious Adverse Events (SAEs) in Those Received LAIV | Incidence of adverse events (AE) and serious adverse events (SAEs) in children receiving LAIV, with the following sub-analyses:
NB: AE data was NOT collected in household controls, as per protocol NB: AE delay not collected in Controls (as per protocol) | AE data was not collected in household controls, as per protocol | Posted | Count of Participants | Participants | Up to 1 month after LAIV administration |
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| 0 |
| 164 |
| 43 |
| 164 |
| Viral upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| >4-fold increase in HI titre to a_eng strain |
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| >4-fold increase in HI titre to b_phu strain |
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| >4-fold increase in HI titre to b_bris strain |
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| >4-fold increase in oral fluid IgA to h1 |
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| >4-fold increase in oral fluid IgA to h3 |
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